US FDA May Fast Track COVID-19 Vaccine Before Phase-3 Trials Complete

US drug regulator is now ready to consider giving emergency authorization to a COVID-19 vaccine even before the end of crucial Phase-3 trials, after Russia and China.

US drug regulator is now willing to consider giving emergency authorization to a COVID-19 vaccine even before the end of crucial Phase-3 trials, after Russia and China, according to the head of US Food and Drug Administration (FDA).//

In an interview with the Financial Times published on Sunday, FDA Commissioner Stephen Hahn said emergency authorization of COVID-19 could be the right decision if the benefits outweigh the risks.

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‘US FDA considers authorization of the COVID-19 vaccine even before the end of crucial Phase-3 trials. ’

The development comes barely a week after US President Donald Trump lashed out at the FDA for its approach to giving drug makers the approvals for testing vaccines and medicines.

Trump accused the FDA of trying to delay the approval process in a bid to harm his prospects in the November elections.

The FDA Commissioner, however, denied that such a move would be influenced by political consideration.

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"It is up to the (vaccine developer) to apply for authorization or approval, and we make an adjudication of their application," Hahn told The Financial Times.

"If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination," he was quoted as saying.

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The Financial Times last week reported that the Trump administration was considering speeding up the availability of an experimental Convid-19 vaccine from the UK ahead of the presidential polls in November.

The vaccine candidate the Trump administration is targeting for fast-tracking is being developed by the Oxford University in partnership with AstraZeneca, said the report.

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Indian council of Medical Research (ICMR) wants to launch indigenous vaccine for COVID-19 by August 15.

Public health officials have warned that giving Covid-19 vaccine approval before completion of Phase-3 trials could amount to compromising on safety concerns.

Source-IANS